eCFR Reference Browser

---

title: "21 CFR §878.4371"

source: "https://www.ecfr.gov/current/title-21/section-878.4371"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "878"

part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"

subpart_code: "E"

subpart_subject: "Surgical Devices"

section_number: "878.4371"

section_subject: "Irrigating wound retractor device."

cfr_reference: "21 CFR 878.4371"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

(b)Classification. Class II (special controls). The special controls for this device are:

(1)The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.

(2)Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.

(3)Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.

(4)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:

(i)Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;

(ii)Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;

(iii)Characterize the forces required to deploy the device;

(iv)Characterize the device's ranges of operation, including flow rates and maximum suction pressures;

(v)Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and

(vi)Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.

(5)The labeling must include or state the following information:

(i)Device size or incision length range;

(ii)Method of sterilization;

(iii)Flammability classification;

(iv)Non-pyrogenic;

(v)Shelf life; and

(vi)Maximum flow rate and suction pressure.

§878.4371 - Irrigating wound retractor device.